Health economic burden that different wound types impose on the UK's National Health Service

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to the management of different wound types by the UK's National Health Service (NHS) in 2012/2013 and the annual costs incurred by the NHS in managing them. This was a retrospective cohort analysis of the records of 2000 patients in The Health Improvement Network (THIN) Database. Patients' characteristics, wound‐related health outcomes and all health care resource use were quantified, and the total NHS cost of patient management was estimated at 2013/2014 prices. The NHS managed an estimated 2·2 million patients with a wound during 2012/2013. Patients were predominantly managed in the community by general practitioners (GPs) and nurses. The annual NHS cost varied between £1·94 billion for managing 731 000 leg ulcers and £89·6 million for managing 87 000 burns, and associated comorbidities. Sixty‐one percent of all wounds were shown to heal in an average year. Resource use associated with managing the unhealed wounds was substantially greater than that of managing the healed wounds (e.g. 20% more practice nurse visits, 104% more community nurse visits). Consequently, the annual cost of managing wounds that healed in the study period was estimated to be £2·1 billion compared with £3·2 billion for the 39% of wounds that did not heal within the study year. Within the study period, the cost per healed wound ranged from £698 to £3998 per patient and that of an unhealed wound ranged from £1719 to £5976 per patient. Hence, the patient care cost of an unhealed wound was a mean 135% more than that of a healed wound. Real‐world evidence highlights the substantial burden that wounds impose on the NHS in an average year. Clinical and economic benefits to both patients and the NHS could accrue from strategies that focus on (a) wound prevention, (b) accurate diagnosis and (c) improving wound‐healing rates.     

Cost of managing patients with venous leg ulcers

The aim of this study was to estimate costs associated with the management of patients with venous leg ulcers (VLUs) from the perspective of the UK National Health Service (NHS). The analysis was undertaken through the Secure Anonymised Information Linkage Databank which brings together and anonymously links a wide range of person‐based data from around 75% of general practitioner (GP) practices within Wales (population coverage ~2.5 million). The data covered an 11‐year period from 2007 to 2017. All patients linked to the relevant codes were tracked through primary care settings, recording the number of GP practice visits (number of days with an event recorded), and wound treatment utilisation (eg, dressings, bandages, etc.) Resources were valued in monetary terms (£ sterling) and the costs were determined from national published sources of unit costs. This is the first attempt to estimate the costs of managing of VLUs using routine data sources. The direct costs to the Welsh NHS are considerable and represent 1.2% of the annual budget. Nurse visits are the main cost driver with annual estimates of £67.8 million. At a UK level, these costs amount to £1.98 billion. Dressings and compression bandages are also major cost drivers with annual Welsh estimates of £828 790. The direct cost of managing patients with VLUs is £7706 per patient per annum, which translates to an annual cost of over £2 billion, when extrapolated to the UK population. The primary cost driver is the number of district nurse visits. Initiatives to reduce healing times through improving accuracy of initial diagnosis, and improved evidence‐based treatment pathways would result in major financial savings.     

Estimating the costs associated with the management of patients with chronic wounds using linked routine data

Chronic wounds are known to represent a significant burden to patients and National Health Service (NHS) alike. However, previous attempts to estimate the costs associated with the management of chronic wounds have been based on literature studies or broad estimates derived from incidence rates and extrapolations from relatively small‐scale studies. The aim of this study is therefore to determine the extent of resource utilisation by patients classed as having chronic wounds within Wales using linked routine data – available through the Secure Anonymised Information Linkage (SAIL) database – to estimate the costs associated with the management of these patients by the NHS in Wales. The SAIL database brings together, and anonymously links, a wide range of person‐based data from general practitioner (GP) practices within Wales, which includes primary and secondary care consultations to create an encrypted anonymised linking field for each individual. This linkage allows the patient pathway to be tracked through the NHS system both retrospectively and prospectively from a specific reference date. The estimated costs were derived by extrapolating to an all‐Wales level from the results gleaned from the SAIL database using the respective READ codes to capture relevant patients with chronic wounds. The number of patients identified as having chronic wounds within the SAIL database was 78 090, which equates to 190 463 across Wales as a whole and a prevalence of 6% of the Welsh population. The total cost of managing patients with chronic wounds in Wales amounted to £328·8 million – an average cost of £1727 per patient and 5·5% of total expenditure on the health service in Wales. A relatively few READ codes represented a significant proportion of expenditure, with diabetic foot ulcers, leg ulcers, foot ulcers, varicose eczema, bed sores and postoperative wound care constituting 93% of total expenditure. When a more conservative perspective was used in relation to classification of chronic wounds, the total cost amounted to £303 million. However, these are likely to be underestimates because of the lack of information for patients with treatments lasting over 6 months and not including patients who might have entered the health care system of wound management elsewhere – such as patients contracting pressure ulcers in hospitals and having surgical wound infections.     

A pilot multi‐centre prospective randomised controlled trial of RECELL for the treatment of venous leg ulcers

Venous leg ulcers (VLUs) have a significant impact on approximately 3% of the adult population worldwide, with a mean NHS wound care cost of £7600 per VLU over 12 months. The standard care for VLUs is compression therapy, with a significant number of ulcers failing to heal with this treatment, especially with wound size being a risk factor for non‐healing. This multicentre, prospective, randomised trial evaluated the safety and effectiveness of autologous skin cell suspension (ASCS) combined with compression therapy compared with standard compression alone (Control) for the treatment of VLUs. Incidence of complete wound closure at 14 weeks, donor site closure, pain, Health‐Related Quality of Life (HRQoL), satisfaction, and safety were assessed in 52 patients. At Week 14, VLUs treated with ASCS + compression had a statistically greater decrease in ulcer area compared with the Control (8.94 cm² versus 1.23 cm², P = .0143). This finding was largely driven by ulcers >10 to 80 cm² in size, as these ulcers had a higher mean percentage of reepithelialization at 14 weeks (ASCS + compression: 69.97% and Control: 11.07%, P = .0480). Additionally, subjects treated with ASCS + compression experienced a decrease in pain and an increase in HRQoL compared with the Control. This study indicates that application of ASCS + compression accelerates healing in large venous ulcers.     

Measuring costs and quality of life for venous leg ulcers

Venous leg ulcers (VLUs) result in substantial economic costs and reduced quality of life (QoL); however, there are few Australian cost estimates, especially using patient‐level data. We measured community‐setting VLU management costs and the impact on the QoL of affected individuals. VLU patients were recruited from a specialist wound clinic, an outpatient clinic, and two community care clinics in Queensland. Cost data were collected at the baseline visit. QoL (EQ‐5D‐5L) and wound status data were collected at baseline, 1, 3, and 6 months. Patients were classified into guideline‐based/optimal care and usual care groups. Average weekly costs per patient were statistically significantly different between the usual care and optimal care groups—$214.61 and $294.72, respectively (P = 0.04). Baseline average QoL score for an unhealed ulcer was significantly higher in the optimal care group compared with usual care (P = 0.025). Time to healing differed between the usual care group and the optimal care group (P = 0.04), with averages of 3.9 and 2.7 months, respectively. These findings increase the understanding of the costs, QoL, and healing outcomes of VLU care. Higher optimal care costs may be offset by faster time to healing. This study provides data to inform an economic evaluation of guideline‐based care for VLUs.     

A conceptual framework of patient‐reported outcomes in people with venous leg ulcers

Venous leg ulcers (VLUs) are a common chronic often undertreated condition, which affects individual's health‐related quality of life (HRQoL). Numerous patient‐reported outcome measures (PROMs) have been validated to capture HRQoL in patients with VLUs. However, available instruments contain many items, are hard to use in clinical practice, and present with weak responsiveness. This study aims to determine clinical utility of an existing VLU‐QoL instrument and to develop a comprehensive PROs assessment framework to guide clinical practice treatment in people with VLUs in Australia. Semi‐structured qualitative interviews were conducted with VLU patients (N = 13) and their managing clinicians (N = 6) in Victoria, Australia. Interview topics covered content and face validity, appropriateness, and acceptability of the VLU‐QoL instrument to determine suitable and appropriate for use in clinical practice. Clinicians and patients agreed that a VLU‐QoL instrument was needed in clinical practice. Both clinicians and patients agreed it would be appropriate to answer PROMs questions prior to consultation with clinicians every 3–6 months. However, patients considered that some of the questions are ambiguous and too technical. Patients reported that it would be useful to include additional items relating to daily wound care, compression bandaging, and dressings. Clinicians reported that the VLU‐QoL instrument was too long and required restructuring to facilitate utility in practice. A conceptual framework for HRQoL in VLUs included traditional HRQoL components and VLU‐specific issues. Overall, the VLU‐QoL was well accepted, although changes to make it more concise, comprehensive, and to clearly reflect consumers' perspectives were lacking. The proposed conceptual framework will inform the development of a new PROM for use by clinicians and patients in clinical settings.     

Validation of inpatient international classification of disease ninth revision codes as predictors of venous leg ulcers

Venous leg ulcers (VLU) comprise about 70% of lower leg wounds and cost more than 14 billion USD per year. Patients with VLU are often admitted to the hospital; however, epidemiological study of this important patient subset is challenged by lack of validated database search protocol. Five International Classification of Diseases (ICD) 9 codes were identified for their relationship with VLUs (454.0, 454.2, 459.11, 707.9, and 707.10). The ICD9 code was considered to successfully predict a VLU if the wound was located in the gaiter area and had either relevant clinical findings, a positive venous study, and/or a diagnosis of VLU written in the physician note. The code 454.0, when combined with length of admission and subjects’ age, yielded high specificity (100%) and positive predictive value (100%), sacrificing sensitivity (34.4%). This formula represents a viable search criterion to identify VLU patients in large‐scale datasets to examine patients’ outcomes, costs, and comorbidities.     

Epidemiology and use of compression treatment in venous leg ulcers: nationwide claims data analysis in Germany

Chronic venous diseases are the most common causes of leg ulcers. Compression treatment (CT) is a central component of venous leg ulcer (VLU) therapy along with prevention based on guidelines and clinical evidence. However, large‐scale data on the use of CT are rare. In particular, there have not yet been published nationwide data for Germany. We analysed data from a large German statutory health insurance (SHI) on incident VLU between 2010 and 2012. VLUs were identified by ICD‐10 diagnoses. The status of active disease was defined by wound‐specific treatments. Compression stockings and bandages were identified by SHI medical device codes. The overall estimated incident rate of active VLU of all insured persons was 0·34% from 2010 to 2012. Adapted to the overall German population, n = 229 369 persons nationwide had an incident VLU in 2010–2012. Among all VLU patients, only 40·6% received CT within 1 year, including 83·3% stockings, 31·8% bandages and 3·1% multi‐component compression systems. Compression rates showed significant differences by gender and age. Large regional variations were observed. Validity of data is suggested by high concordance with a primary cohort study. Although recommended by guidelines, there is still a marked under‐provision of care, with CT in incident VLUs in Germany requiring active measures.     

A real‐world experience with the bioactive human split thickness skin allograft for venous leg ulcers

Data collected from standardized clinical practices can be valuable in evaluating the real‐world therapeutic benefit of skin substitutes in the treatment of venous leg ulcers (VLU). Utilizing such a dataset, this study aimed to validate the effectiveness of a bioactive human split‐thickness skin allograft for the treatment of VLU in the real‐world setting and to understand how certain variables impacted healing rates. From a pool of 1474 VLU treated with allograft, 862 ulcers in 742 patients were selected from a large wound EMR database and analyzed. All patients received standard wound care prior to allograft application. Impact of ulcer duration, number of applications, ulcer size, and time to application were analyzed. The VLU, on average, were of 189 days duration with a mean ulcer size of 19.3 cm². During treatment, 70.7% of wounds healed, with an average time to closure of 15 weeks (SD = 14.1 weeks). The percentage of VLU less than one‐year duration that healed was significantly higher (72.3%) than the percentage of VLU with duration of greater than 1 years (51.5%) ( χ² = 18.17 ; P < .001). Ulcers less than 10 cm² in size were more likely to heal (73.9%) than those larger than 10 cm² (67.9%) ( χ² = 8.65, P = .03). VLU receiving allograft within 90 days of initial presentation are 1.4 times more likely to heal vs those receiving their first BSA application after 90 days of standard of care (95% CI: [1.05, 1.86], P = .02). Allograft used in wound clinics healed a majority of refractory VLU, even in large ulcers of long duration, which are more difficult to heal. Smaller wound, size, and shorter wound duration were associated with greater likelihood of healing. VLUs treated earlier with allograft had better healing outcomes. Clinicians may consider more aggressive and timely treatment with allograft for refractory VLU.     

Cost‐of‐illness of chronic leg ulcers in Germany

Chronic wounds are important because of their frequency, their chronicity and high costs of treatment. However, there are few primary data on the cost‐of‐illness in Germany. The aim was to determine the cost‐of‐illness of venous leg ulcers (VLU) in Germany. Prospective cost‐of‐illness study was performed in 23 specialised wound centres throughout Germany. Direct, medical, non medical and indirect costs to the patient, statutory health insurers and society were documented. Thereover, health‐related quality of life (QoL) was recorded as intangible costs using the Freiburg quality of life assessment for wounds (FLQA‐w, Augustin). A total of 218 patients (62.1% female) were recruited consecutively. Mean age was 69.8 ± 12.0 years. The mean total cost of the ulcer per year and patient was € 9569, [ € 8658.10 (92%) direct and € 911.20 (8%) indirect costs]. Of the direct costs, € 7630.70 was accounted for by the statutory health insurance and € 1027.40 by the patient. Major cost factors were inpatient costs, outpatient care and non drug treatments. QoL was strikingly reduced in most patients. In Germany, VLU are associated with high direct and indirect costs. As a consequence, there is a need for early and qualified disease management. Deeper‐going cost‐of‐illness‐studies and cost‐benefit analyses are necessary if management of chronic wounds is to be improved.     

A randomized,controlled, double‐blind prospective trial with a Lipido‐Colloid Technology‐Nano‐OligoSaccharide Factor wound dressing in the local management of venous leg ulcers

Venous leg ulcers (VLUs) are the most prevalent chronic wounds in western countries with a heavy socioeconomic impact. Compression therapy is the etiologic treatment of VLU but until now no wound dressing has been shown to be more effective than another. The aim of this study was to assess the efficacy of a new dressing in the management of VLU. Adult patients presenting a noninfected VLU and receiving effective compression therapy were enrolled in this randomized, controlled, double‐blind trial. The VLUs were assessed every 2 weeks for 8 weeks. The primary study outcome was the relative Wound Area Reduction (WAR, in %), and the secondary objectives were absolute WAR, healing rate, and percentage of wounds with >40% surface area reduction. One hundred eighty‐seven patients were randomly allocated to treatment groups. Median WAR was 58.3% in the Lipido‐Colloid Technology‐Nano‐OligoSaccharide Factor (TLC‐NOSF) dressing group (test group) and 31.6% in the TLC dressing group (control group) (difference: ?26.7%; 95% confidence interval: ?38.3 to ?15.1%; p = 0.002). All other efficacy outcomes were also significant in favor of the TLC‐NOSF dressing group. Clinical outcomes for patients treated with the new dressing are superior to those patients treated with the TLC dressing (without NOSF compound), suggesting a strong promotion of the VLU healing process.     

Depressive symptoms in patients with wounds: A cross‐sectional study

Depression slows wound healing in patients with chronic wounds. The prevalence of depressive symptoms differs in the literature and the current understandings of factors related to depression in patients with wounds have been limited. To investigate the prevalence of depressive symptoms and the associated factors in patients with wounds, we performed this retrospective study in which depressive symptoms were evaluated with the Patient Health Questionnaire 9‐item (PHQ‐9). Valid PHQ‐9 scores were collected from 222 patients (112 males and 110 females; age: 64.1 ± 15.8) out of 260 consecutive patients evaluated at an outpatient physical therapy wound clinic during 2012–2015. The proportion of patients with minimal to severe depressive symptoms was 81.5% [80.8% in patients with venous leg ulcers (VLUs) and 82.0% in non‐VLUs]; 22.1% patients with wounds had scored positive for depression (moderate to severe depressive symptoms). Specific proportions of positive depression screening were 26.6% in patients with VLUs and 18.8% in non‐VLU patients, and 14.1 and 40.0% in patients with wounds <90 and ≥ 90 days as of initial examination, respectively. PHQ‐9 scores were significantly decreased from 5.85 ± 6.01 at initial examination to 3.42 ± 4.35 at last visit (p < 0.001). The odds of a positive depression screening was 3.20 (95% CI = [1.49, 6.87]) in patients with wounds ≥ 90 days (vs. < 90 days) and 2.53 (95% CI = [1.26, 5.08]) in patients with pain related to the wounds (vs. without pain), after patients’ age, gender, and race were controlled for. No difference was found in proportions of positive depression screening between VLUs and other wound diagnoses. Depressive symptoms were common in patients with wounds, especially in patients with wounds ≥90 days and with pain related to the wounds at initial examination. Therefore, clinicians should take into consideration patients’ mental status upon management of wounds.     

A prospective study on the wound healing and quality of life outcomes of patients with venous leg ulcers in Singapore—Interim analysis at 6 month follow up

Venous leg ulceration results in significant morbidity. However, the majority of studies conducted are on Western populations. This study aims to evaluate the wound healing and quality of life for patients with venous leg ulcers (VLUs) in a Southeast Asian population. This is a multi-centre prospective cohort study from Nov 2019 to Nov 2021. All patients were started on 2- or 4-layer compression bandage and were reviewed weekly or fortnightly. Our outcomes were wound healing, factors predictive of wound healing and the EuroQol 5-dimensional 5-level (EQ-5D-5L) health states. Within our cohort, there were 255 patients with VLU. Mean age was 65.2 ± 11.6 years. Incidence of diabetes mellitus was 42.0%. Median duration of ulcer at baseline was 0.30 years (interquartile range 0.136–0.834). Overall, the median time to wound healing was 4.5 months (95% confidence interval [CI]: 3.77–5.43). The incidence of complete wound healing at 3- and 6-month was 47.0% and 60.9%, respectively. The duration of the wound at baseline was independently associated with worse wound healing (Hazard ratio 0.94, 95% CI: 0.89–0.99, P = .014). Patients with healed VLU had a significantly higher incidence of perfect EQ-5D-5L health states at 6 months (57.8% vs 13.8%, P < .001). We intend to present longer term results in subsequent publications.     

Reduction in wound healing times,cost of consumables and number of visits treated through the implementation of an electronic wound care system in rural Australia

Globally, wound care costs the health care system 2–3% of the total expenditure on health, which equates to several billion dollars annually. To date, there are little data on the cost and healing rates of various wounds. This has been partly because of the difficulty in tracking wound management as the majority of wound care data has been focused on retrospective data from hospitals, general practice clinics and aged care facilities. This study reports on wound healing and cost of wounds collected from a larger project using the mobile wound care (MWC) electronic documentation system, which has been described elsewhere. The study involved 2350 clients from four health service districts in the Gippsland region in rural Australia who received treatments as part of the MWC research project (2010–2012), with a total of 3726 wounds identified (so an average of 1·6 wounds per client). By the end of the data collection period, 81% of these wounds had healed. A significant drop in healing time, cost of consumables and number of visits was found across the 3‐year period.     

Poor survival of dialysis patients with unhealed wounds because of critical limb ischemia: Limb salvage and survival requires wound healing

Maintenance of blood flow in the wound area is required to heal wounds of critical limb ischemia (CLI) in dialysis patients. However, many dialysis patients have both a stenotic lesion in below‐knee blood vessels and a cardiovascular event as complications, and thus, it may be difficult to ensure sufficient blood flow. Therefore, many deaths occur because of problems with wound healing. The aim of this study is to identify the optimal treatment, including revascularisation and amputation, from the perspective of wound healing by analysing the survival of hemodialysis patients with CLI who had healed or unhealed wounds in a lower extremity. The subjects were 52 patients who received maintenance dialysis at our clinic, including 27 with healed CLI wounds and 25 with unhealed CLI wounds. The Kaplan‐Meier method was used to compare survival between the two groups. Multivariate analysis was conducted to examine the effect of an unhealed wound on mortality. The mean follow‐up period was 1.7 ± 1.1 years. In the unhealed wound group, the 1‐, 2‐, and 3‐year survival rates were 48%, 20%, and 12%, respectively. The overall survival rate was significantly lower in the unhealed wound group compared with the healed wound group (12% vs 63%, P = .0002 by log‐rank test). In multivariate analysis, unhealed CLI wounds had a significant independent association with mortality (hazard ratio 3.32; 95% confidence interval [CI]: 1.41‐8.77, P = .0054). In this study, the 3‐year survival rate suggested a significantly poorer prognosis of hemodialysis patients with unhealed CLI wounds compared with those with healed wounds. An unhealed wound is an independent risk factor for mortality in hemodialysis patients with CLI.     

Adalimumab treatment leads to reduction of tissue tumor necrosis factor‐alpha correlated with venous leg ulcer improvement: a pilot study

Venous leg ulcers (VLUs) have higher tumor necrosis factor‐α (TNF‐α) levels compared with normal skin. Refractory VLUs of long duration have higher TNF‐α levels compared with VLUs of shorter duration. As up to 75% of VLUs fail to heal with standard care, we sought to evaluate the role of anti‐TNF‐α therapy for patients with refractory VLUs. Evaluable data were obtained in four of five subjects with recalcitrant VLUs treated with 80 mg of subcutaneous adalimumab at week 0 and with 40 mg at week 2 along with compression therapy and were followed‐up for 6 weeks. Wound biopsies taken at weeks 0 and 4 were stained with anti‐TNF‐α antibodies. Average 4‐week percent wound size reduction was 20.5% ± 6.4%. Two patients had wound size reduction more than 25%, and their percent wound size reduction correlated to percent TNF‐α staining score reductions (P = 0.02, R² = 0.999). VLU TNF‐α level decrease 4 weeks post‐adalimumab treatment correlated with wound healing.     

Cost−utility analysis of shockwave lithotripsy vs ureteroscopic stone treatment in adults

Objectives

To assess the cost-effectiveness, resource use implications, quality-adjusted life-years (QALYs) and cost per QALY of care pathways starting with either extracorporeal shockwave lithotripsy (SWL) or with ureteroscopic retrieval (ureteroscopy [URS]) for the management of ureteric stones.

Patients and Methods

Data on quality of life and resource use for 613 patients, collected prospectively in the Therapeutic Interventions for Stones of the Ureter (TISU) randomized controlled trial (ISRCTN 92289221), were used to assess the cost-effectiveness of two care pathways, SWL and URS. A health provider (UK National Health Service) perspective was adopted to estimate the costs of the interventions and subsequent resource use. Quality-of-life data were calculated using a generic instrument, the EuroQol EQ-5D-3L. Results are expressed as incremental cost-effectiveness ratios and cost-effectiveness acceptability curves.

Results

The mean QALY difference (SWL vs URS) was −0.021 (95% confidence interval [CI] −0.033 to −0.010) and the mean cost difference was −£809 (95% CI −£1061 to −£551). The QALY difference translated into approximately 10 more healthy days over the 6-month period for the patients on the URS care pathway. The probabaility that SWL is cost-effective is 79% at a society's willingness to pay (WTP) threshold for 1 QALY of £30,000 and 98% at a WTP threshold of £20,000.

Conclusion

The SWL pathway results in lower QALYs than URS but costs less. The incremental cost per QALY is £39 118 cost saving per QALY lost, with a 79% probability that SWL would be considered cost-effective at a WTP threshold for 1 QALY of £30 000 and 98% at a WTP threshold of £20 000. Decision-makers need to determine if costs saved justify the loss in QALYs.     

Quality of life of adults with unhealed and healed diabetic foot ulcers

BACKGROUND: Diabetic foot ulcers cause major treatment morbidity and cost of care. This study evaluated quality of life in patients with unhealed and healed diabetic foot ulcers. METHODS: This was a cross-sectional study of adult diabetic patients (age 45 years or older) treated in a tertiary care foot clinic who had foot ulcers within the preceding 2 years. Patients with other diabetic complications or conditions that would potentially affect quality of life were excluded. Two patient groups of comparable age, gender distribution, and duration of diabetes were studied: 57 patients with unhealed ulcers (minimum duration, 6 months) and 47 patients with healed ulcers. Telephone interviews were done using the Short Form 12 (SF-12) (both groups) and a Cardiff Wound Impact Scale (CWIS) (unhealed ulcer group). RESULTS: The mean SF-12 Physical Component Summary score was significantly lower for the group with unhealed ulcers (unhealed, 35 +/- 8 points; healed, 39 +/- 10 points; p = 0.04); these scores for both groups were significantly lower than published Short Form 36 (SF-36) scores for general, diabetic, and hypertensive populations. The mean SF-12 Mental Component Summary scores of the groups did not differ significantly from each other or from published population scores. CWIS responses showed that patients with unhealed ulcers were frustrated with healing and had anxiety about the wounds, resulting in marked negative impact on the average Well-being Component Score (35 +/- 6 points). CONCLUSIONS: Individuals with diabetic foot ulcers experience profound compromise of physical quality of life, which is worse in those with unhealed ulcers.